Τοποθεσία Αθήνα πριν 6 μέρες Ημ. ανάρτησης πριν 6 μέρες Με κάποια εμπειρία Επίπεδο εμπειρίας Με κάποια εμπειρία Μερική απασχόληση Τύπος απασχόλησης Μερική απασχόληση Φαρμακευτικά / Υγεία Κατηγορία θέσης Φαρμακευτικά / Υγεία Εργασία απο απόσταση Τηλεργασία Εργασία απο απόσταση
Fertithera Labs is a fast-growing Greek Pharmaceutical Company with headquarters in Thessaloniki.

Fertithera Labs invites applications from career-oriented professionals for the position of Regulatory and Pharmacovigilance Specialist in Athens, Greece. (starting part time and potentialy full time in the future)

What the job looks like?

Review regulatory documentation related to Module 1 for DCP, MRP and RUP applications in line with the appropriate timelines

Be responsible for the submission of new dossiers, renewals and variations due to dossier updates for existing products, in e CTD format and in compliance with the global regulations in force

Liaise with external Regulatory authorities as required for the successful completion of projects

Liaise with the appropriate departments within the company to collect all necessary information for the submission of pharmaceutical dossiers and product registration

Ensure policies and procedures are properly evaluated, implemented and carried out, safeguarding the compliance of company

Co-ordinate and support licence-in & license-out products, ensuring smooth progress of all procedures

Monitoring the progress of DCP, MRP and RUP and their finalization in a timely and accurate manner

Review and supervision of PV reporting as per regulatory and internal timelines

Conduct database searches, screen and review global/local literature as required

Quality Control/ Review of ICSRs

Prepare and review the Periodic Safety Update Reports (PSUR)

Prepare and review Signal Management Reports

Preparation and review of written procedures

Proposals for improvement of PV procedures/processes

Participation in Audits, Inspections

Advisory/Training role in PSURs, Signal, ICSR assessment

Review of PV legislation updates, documentation, communication and action planning

Perform PV training to employees and partners

Requirements

University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset

At least 2-3 years of experience in the pharmaceutical sector, in the field of Regulatory Affairs and / or Pharmacovigilance

Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines

Experience in PSUR (Periodic Safety Update Reports) and Med DRA coding

Experience in Signal Management will be considered as asset

Ability to work collaboratively in a team, and prioritize work in a dynamic and fast changing environment

Strong communication, influencing and problem resolution skills

Strong organization skills and able to meet deadlines

Ability to be adaptive to change, to multitask and give attention to detail

Very good interpersonal skills, analytical thinking and result orientation

Fluency in Greek and English (written and spoken) and computer literacy. Knowledge of any other languages will be considered an asset

Ability to travel abroad if requested

By joining us you can expect:
We are offering an attractive remuneration package (including medical insurance) and a challenging opportunity for professional development.

If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please submit your CV below.

All applications will be treated with strict confidentiality. Only shortlisted candidates will be contacted.